Status:
COMPLETED
Postoperative Melatonin Administration and Delirium Prevention in Patients Undergoing Vascular and Cardiac Surgery
Lead Sponsor:
University Health Network, Toronto
Conditions:
Cardiac Surgery
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
The investigators plan to evaluate the effect of postoperative melatonin administration on postoperative delirium in patients undergoing vascular and cardiac surgery. A total of 302 patients older tha...
Eligibility Criteria
Inclusion
- Non-emergent vascular surgery, with an expected length of stay ≥ 48hours, ASA categories I to IV, signed informed consent, age \>60
Exclusion
- Lack of informed consent, ASA category V, history of psychiatric illness (schizophrenia, psychosis, bipolar disorder, major depression), Mini Mental State Examination score (MMSE) ≤ 24, history of autoimmune disease, liver cirrhosis, minimally invasive procedures (endovascular aneurysm repair ), history of chronic insomnia, chronic benzodiazepines and/or hypnotics use ( \> 3 times /week during a month prior to surgery), treatment with tricyclic antidepressants within a month prior to surgery, history of seizures, allergy to placebo ingredients or melatonin ( WN Pharmaceuticals.LTD), melatonin consumption in the last months prior to surgery.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01198938
Start Date
August 1 2010
End Date
February 1 2013
Last Update
February 22 2013
Active Locations (1)
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1
Toronto General Hospital, UHN
Toronto, Ontario, Canada, M5G 2C4